Table 3.

Use of Celecoxib and Risk of Adenomas.³⁵

Variable	Placebo (N = 679)	Celecoxib 200 mg twice daily (N = 685)	Celecoxib 400 mg twice daily (N = 671)
Detection of any adenoma
All patients
Year 1 colonoscopy—no. with adenoma/total no. at risk (%)	271/608 (44.6)	186/613 (30.3)	137/601 (22.8)
Year 3 colonoscopy—no. with adenoma/total no. at risk (%)	83/286 (29.0)	66/357 (18.5)	76/400 (19)
Cumulative incidence of adenomas detected through year 3 (%)	60.7 ± 2.1	43.2 ± 2.1	37.5 ± 2.1
Risk ratio (95% CI)	—	0.67 (0.59-.77)	0.55 (0.48-0.64)
P value	—	<.001	<.00
Patients taking aspirin
Cumulative incidence of adenomas detected through year 3 (%)	59.9 ± 3.7	45.7 ± 3.8	38.2 ± 3.8
Risk ratio (95% CI)	—	0.71 (0.57-0.90)	0.55 (0.43-0.72)
P value	—	.004	<.001
Patients not taking aspirin
Cumulative incidence of adenomas detected through year 3 (%)	60.9 ± 2.5	42.1 ± 2.5	37.2 ± 2.4
Risk ratio (95% CI)	—	0.65 (0.55-0.77)	0.55 (0.46-0.65)
P value	—	<.001	<.001
Sensitivity analysis imputing adenoma for patients without an end point determination
Cumulative incidence of adenoma detected through year 3 (%)	70.1 ± 1.8	57.5 ± 1.9	51.7 ± 1.0
Risk ratio (95% CI)	—	0.76 (0.69-0.85)	0.66 (0.59-0.73)
P value	—	<0.001	<0.001
Analysis of patients who adhered to protocol
Cumulative incidence of adenoma detected through year 3 (%)	60.7 ± 2.8	38.8 ± 2.8	35.4 ± 2.7
Risk ratio (95% CI)	—	0.59 (0.48-0.73)	0.51 (0.41-0.64)
P value	—	<.001	<.001
Detection of advanced adenomas
All patients
Year 1 colonoscopy—no. with adenoma/total no. at risk (%)	67/608 (11.0)	26/613 (4.2)	27/601 (2.8)
Year 3 colonoscopy—no. with adenoma/total no. at risk (%)	32/459 (7.0)	18/487 (3.7)	18/503 (3.6)
Cumulative incidence of adenomas detected through year 3 (%)	17.2 ± 1.6	7.8 ± 1.1	6.3 ± 1.0
Risk ratio (95% CI)	—	0.43 (0.31-0.61)	0.34 (0.24-0.50)
P value	—	<.001	<.001

Note. CI = confidence interval.